Addressing the America Invents Act proceedings for the first time, the Supreme Court’s decision in Cuozzo Speed Technologies LLC v. Lee largely maintained the status quo. The Court held that the Patent Trial and Appeal Board’s (PTAB) determination on whether to institute an inter partes review is not appealable in…
Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed four-letter suffixes and, optionally, analyses supporting those suffixes. FDA has now announced that it is withdrawing…
As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA to impose stricter labeling requirements on biosimilar applicants. Last month, the Generic Pharmaceutical Association (GPhA) submitted a comment in opposition…
As we posted earlier this morning, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the announcement, and an overview of what we can expect next. Analysis The Court’s move indicates a substantial degree of…
The Supreme Court today invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari–see page two of today’s order list: http://www.supremecourt.gov/orders/courtorders/062016zor_e2q3.pdf. See our post here for recent coverage on the petitions, and stay tuned for further updates.
In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone Laboratories, Celltrion’s Utah-based supplier of cell culture media. These complaints follow Judge Wolf’s recent order in Janssen’s original…
Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of people with type 1 and type 2 diabetes. In both Phase III studies, MK-1293 demonstrated statistical…
According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its 2013 value. Six biosimilars have been approved in South Korea since 2012, and dozens of other biosimilars are currently in the development…
As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision—subsection (l)(8)(A)—as authorizing such notice only after FDA approval of an aBLA. In response, on March 21, Amgen…
Yesterday, the Federal Circuit issued a final decision in Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720 case affirming two PTAB IPR final decisions invalidating as obvious the claims of U.S. Patent Nos. 7,351,410 and 7,655,226, which are directed to the treatment of Pompe’s disease with injections of human acid…